CA0881007 (QUINTESSENTIAL-2) BMS-986393 in RR and LEN refractory MM
Research type
Research Study
Full title
A Phase 3, Randomized, Open-Label, Multicenter Study to Compare the Efficacy and Safety of Arlocabtagene Autoleucel (BMS-986393), a GPRC5D-directed CAR-T Cell Therapy, Versus Standard Regimens in Adult Participants with Relapsed or Refractory and Lenalidomiderefractory exposed Multiple Myeloma (QUINTESSENTIAL-2)
IRAS ID
1010535
Contact name
GSM-CT Representative
Contact email
Sponsor organisation
Celgene Corp.
Clinicaltrials.gov Identifier
Research summary
Multiple myeloma is a type of blood cancer that affects cells in your bones called plasma cells. These cells help your body fight infections. Even with new treatments, multiple myeloma cannot be cured, and the disease often comes back, which is called a relapse. At each relapse, it gets harder to treat and some treatments stop working, which is called being refractory.
When patients become refractory to a drug called lenalidomide, their chances of survival go down, so new treatments are needed. One new treatment, called BMS-986393, is a (CAR) T-cell therapy. It uses the patient's own immune cells (T-cells), which are modified to find and attack multiple myeloma cells by targeting a protein on their surface called GPRC5D. Results from another study of BMS-986393 show the drug seems to work and has side effects that doctors can manage.
This new study aims to see if BMS-986393 works better than two other common treatments, DPd [daratumumab, pomalidomide, dexamethasone] or Kd [carfilzomib, dexamethasone], in adults with multiple myeloma that has come back or stopped responding to lenalidomide. Participants will be randomly assigned (like flipping a coin) to receive either BMS-986393 (study arm A) or one of the other treatments, DPd or Kd (study arm B). Participants in arm A will have T-cells taken from their blood and receive chemotherapy before receiving BMS-986393. Participants in arm B will receive either DPd or Kd as their treatment. After treatment, all participants will be checked regularly.
Study tests will include physical and neurological exams, heart and body scans, bone marrow tests/biopsies, ECG, vital signs (blood pressure, heart rate, temperature and oxygen levels), height and weight measurements, blood and urine tests and health-related questionnaires. The study is expected to last about 89 months.REC name
South Central - Berkshire B Research Ethics Committee
REC reference
25/SC/0007
Date of REC Opinion
6 Mar 2025
REC opinion
Further Information Favourable Opinion